Assistant Manager, Facilities and Engineering - Integrated Resources, Inc
Dayton, NJ 08810
About the Job
Job Title: Assistant Manager, Facilities and Engineering
Locating: : Dayton, NJ
Duration: Full Time (FTE/Permanent/Contract to Hire)
Job Description:
Responsibilities:
Qualification:
Education:
Locating: : Dayton, NJ
Duration: Full Time (FTE/Permanent/Contract to Hire)
Job Description:
- The individual is required to coordinate planning, implementation, documentation and support manufacturing and laboratory operations and plant facilities.
- The role has to coordinate with all internal and external customers in a GxP environment by ensuring all activities and documentation is complaint with good documentation practices, quality compliance requirements, and applicable standard operating procedures.
Responsibilities:
- Manage the team to schedule work orders based on the priorities and ensure all documentation is compliant with Good documentation practices.
- Ability to check and respond to the Client/EMS alerts.
- Understand quality systems to include; Change Control, Deviations, CAPA s, Investigations and Audits.
- Plan and maintain spares and consumables for min-max and re-order levels.
- Schedule and coordinate periodic maintenance work / calibrations with external agencies as applicable.
- Adept in using CMMS and ERP.
- Must train people on the SOP belonging to respective departments by preparing question banks, initiating a self-study course or offline course or external training in Nichelon.
- Preparation of master equipment list.
- Preparation and finalization of preventive maintenance checklist and schedules.
- Preparation of master calibration list and calibration schedules.
- Ensure the execution of preventive maintenance and calibration schedules with internal or external sources.
- Review and verification of all calibration certification details and their archival.
- Issuance, execution and archival of all approved documents on timely basis as per respective SOPs.
- Develop procedures to induct new machines and maintenance procedures and coordinate with stake holders to ensure safe and compliant installation on time.
- Increase Safety Awareness and address any safety issues and concerns and ensures that equipment m.eets all relevant Health, Safety and Environment requirements
Qualification:
- Experience with Microsoft Office products, such as Excel, Word, and Outlook.
- Strong planning, organization and prioritization skills with an ability to lead a team of mechanics.
- Ability to work independently with minimal direction and supervision.
- Intermediate ability to write reports, justifications, procedures, work orders and investigations.
- Must be able to communicate effectively with departmental staff, both written and verbal.
- A strong work ethic, integrity, stability, sense of urgency, fairness, and a desire and willingness to take ownership and assume responsibility for the operation.
- A team player with a cooperative and logical workstyle.
Education:
- Prior experience in a pharmaceutical, biopharmaceutical or other GMP regulated industry.
- Boiler Operator Certificate is a must.
- Minimum of 5 years experience in CGMP, QMS and Internal/FDA Audits.
Source : Integrated Resources, Inc
